Director – Clinical Quality

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $200k - $290k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Braveheart Bio

WebsiteLinkedInAll Job Openings

1 - 10 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Braveheart Bio is a clinical-stage biotechnology company focused on transforming the care of hypertrophic cardiomyopathy (HCM) and related conditions. The company is developing investigational therapies that selectively target overactive myosin — a key disease mechanism in HCM — and is advancing a program through global late-stage (Phase 3) clinical development to improve heart performance and patient quality of life.

📋 Description

• Serve as a senior quality leader responsible for clinical quality oversight and inspection readiness for the late-stage hypertrophic cardiomyopathy clinical program • Establish and execute the clinical oversight framework supporting global Phase 3 execution • Guide clinical development teams and prepare the organization for regulatory submissions and commercialization activities • Partner with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, and external CRO and vendor partners on quality oversight • Build and potentially lead a small quality team as the company grows • Lead clinical quality strategy aligned with global regulatory requirements, risk-based quality principles, and business priorities • Establish fit-for-purpose quality practices for late-stage development and inspection readiness • Serve as the company’s GCP subject matter expert and provide quality guidance across clinical development activities • Lead risk-based GCP quality oversight of CROs, vendors, clinical laboratories, and clinical sites • Direct GCP inspection readiness activities and serve as a key quality leader during health authority inspections • Support computerized system validation for clinical systems, including oversight of validation activities and review of validation documentation • Develop and maintain clinical quality study oversight plans • Develop inspection readiness strategies with Quality Compliance and Risk Management • Lead clinical deviation investigations, root cause analysis, and CAPA management • Ensure timely and effective resolution of quality issues • Maintain inspection readiness across clinical activities, documentation, and teams • Collaborate with Legal on GDPR and data privacy requirements • Partner with Data Management, IT, Legal, and vendors on personal-data handling, storage, and transfer • Support data protection impact assessments, vendor privacy assessments, and data processing agreements • Provide quality support to Clinical Operations, Biometrics, Pharmacovigilance, Medical/Clinical Development, Medical Affairs, Nonclinical, and other functions • Participate in project team meetings and cross-functional planning • Provide ad hoc quality support across broader GxP activities • Contribute to cross-functional quality initiatives, inspections, and issue resolution

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, or related discipline; advanced degree preferred • At least 10 years of GCP quality experience, including deep experience in GCP oversight, global clinical development, and late stage development • Strong knowledge of global GxP regulations (GCP, GLP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs • Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions • Proven success establishing and executing clinical oversight in a small or emerging biotech environment • Experience developing quality oversight strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions • Demonstrated expertise in GDPR and clinical data-privacy compliance • Demonstrated experience with computerized system validation for clinical systems in a regulated environment • Strong written and verbal communication skills with a collaborative, team-oriented approach • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity • Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude • Experience in rare disease, cardiovascular, or specialty-disease clinical development • Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA) • Prior experience with data privacy frameworks beyond GDPR (e.g., CCPA) • Audit certification or quality certification (e.g., ASQ) • Experience with GLP (21 CFR Part 58 and OECD) a plus • Employment authorization required; Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires

🏖️ Benefits

• Annual bonus eligibility • Equity eligibility • Comprehensive benefits offering

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume